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FDA 510(k)

ETI BIPOLAR HEMOSTATIC PROBE

K-Number: K031026 · 2003-06-27

Decision Date2003-06-27
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETI BIPOLAR HEMOSTATIC PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Endo-Therapeutics, Inc.. It received FDA 510(k) clearance on 2003-06-27 under 510(k) number K031026. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETI BIPOLAR HEMOSTATIC PROBE?

ETI BIPOLAR HEMOSTATIC PROBE is a medical device that received FDA 510(k) clearance on 2003-06-27. The listed applicant is Endo-Therapeutics, Inc.. The 510(k) number is K031026.

When did ETI BIPOLAR HEMOSTATIC PROBE receive FDA 510(k) clearance?

ETI BIPOLAR HEMOSTATIC PROBE received FDA 510(k) clearance on 2003-06-27, under 510(k) number K031026.

Who is the listed applicant for ETI BIPOLAR HEMOSTATIC PROBE?

The FDA 510(k) record lists Endo-Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETI BIPOLAR HEMOSTATIC PROBE?

The FDA product code for ETI BIPOLAR HEMOSTATIC PROBE is KNS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Endo-Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: KNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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